Method and apparatus for the treatment of blood borne pathogens such as immunodeficiency virus

ABSTRACT

A method and apparatus for destroying blood borne pathogens is disclosed which utilizes a low intensity direct current to generate positive particles from various metals which destroy viral pathogens. A first electrode comprised of a metal such as silver is inserted into a patient&#39;s venous system. Then, a second electrode is placed on the patient&#39;s exterior in the vicinity of the first electrode. A low intensity direct current is applied to the first metal electrode which releases silver cations to be bonded to the virus, resulting in the denaturing of the virus. The first electrode is placed in the venous system of the infected patient via a catheter.

This is a division of application Ser. No. 08/708,083, filed Aug. 30,1996, now U.S. Pat. No. 6,066,489.

FIELD OF THE INVENTION

This invention pertains to treatment of blood borne viral infections andmore particularly concerns antiviral apparatus and methods.

BACKGROUND OF THE INVENTION

Blood borne viral infections are extremely difficult to treat or cureonce a patient is infected with the virus. Blood borne viruses cancompletely inundate the patient (i.e., the “host”) and defeat thepatient's immune system, which almost certainly leads to death of thepatient. Examples of viral infections affecting humans include polio,measles, chicken pox, small pox, mumps, Ebola, the common cold and thehuman immunodeficiency virus (“HIV”). In addition, animals are affectedby other viral infections. For example, cattle can be infected byfoot-and-mouth disease, dogs can be infected by distemper, cats can beinfected by panleukopenia and feline immunodeficiency virus, and hogscan be infected by cholera.

The HIV virus has become a leading cause of death among humans. Theprior art has not provided an effective antiviral agent which caneffectively kill the HIV virus, thereby leading to either a cure or aneffective treatment for infected patients.

The mechanisms of viral infections and specifically the HIV virus willnow be discussed so as to provide background into how the presentinvention acts to kill viruses that have infected a patient. A virus isnot an independent living organism. Outside of living cells, for examplein body fluids, some viruses can remain dormant. They do not reproduce,metabolize, grow or assimilate food. For a virus to live and reproduce,it needs a host cell. Thus, until a virus finds a host cell, it it mayremain dormant in body fluids. During this dormancy period, the virusmay come in contact with a suitable host.

Viruses have many different shapes and sizes. For example, theindividual virus or virions can be spherical, rod-shaped, or can have amany headed configuration. Virions range in size from approximately 0.02microns to approximately 0.25 microns. The smallest living bacterium isapproximately 0.4 microns. Virions are generally comprised of a viralcore which is made up of nucleic acids which carry the viral genes and acapsis of fatty materials and proteins which surrounds the core. In somecases, viral proteins are associated with the nucleic acid in the viralcore. This capsis may be surrounded by an additional lipoproteinenvelope. The virus attacks a cell by causing at least its nucleic acidto enter the cell. The virus then takes over the cell's metabolicmachinery and uses it to make many of copies of itself, thus producingmany new virions. In the case of the HIV virus, the virions are releasedfrom the cell by lysing (i.e., the cell bursts), which destroys thecell. Many of the virions, however, are able to go on to infect othercells, which are eventually killed.

Humans and other animals have developed natural defenses to viruses. Oneof the body's first reactions to infection by a virus is a fever. Feveris often the only response necessary since elevated temperatures candeactivate many viruses. Other viruses cause cells to secrete theprotein interferon. Interferon can inhibit the production of virions inuninfected cells. Another reaction to infection by a virus is theproduction of antibodies and activation of other parts of the body'simmune system, which can inactivate the virus. Different viruses resultin the production of different antibodies.

Part of the immune response of humans and other animals to viralinfection is the production of T-lymphocytes and B-lymphocytes.T-lymphocytes and B-lymphocytes are classes of white blood cells thatfight infection in a manner specific to the infecting agent. “B-cells”produce antibodies while “T-cells” have receptors on their surface thatmate with the antigen of an invading agent. This mating prevents theinvader from infecting other cells until that invading agent can beremoved from the bloodstream by the kidneys. More than ten milliondifferent T-cell receptor patterns are known to exist. Once a specificT-cell has been produced to fight a specific agent, that T-cellcontinues to reproduce so that it is present at the time of the nextinfection by the agent it was created to fight. Approximatelytwo-thousand T-cells can be produced by the body per second in a healthyindividual.

The HIV virus is extremely deadly because it attacks these T-cells,eventually producing so many virions that attack the T-cells that thebody cannot make T-cells fast enough to replace those destroyed by theHIV virus. The specific T-cell targeted by the HIV virus is the T4helper lymphocyte. T4 cells are extremely important to the immunedefense system of a human. T4 cells control the body processes whichproduce immune responses to infections. If a T4 cell determines that aresponse is necessary, it instructs the body's immune system to releaseT8 cytotoxic lymphocytes and antibodies.

When an HIV virion finds a T4 cell, it is believed that it attempts topenetrate the cell wall to gain access to the T4 cell's nucleus. Manybelieve that when the HIV virion contacts a T4 cell, the glycoproteinsGp120 and Gp41 on the exterior of the HIV virion attach the virion toCD4 proteins protruding from the T4 cell's surface. After attachment, itis thought that the HIV virus fuses with the T4 cell and injects capsidprotein P24 with the genomic ribonucleic acid (“RNA”) of HIV and reversetranscriptase, RNaseH, and integrase into the cell. After the HIV virusis injected into the cell, the reverse transcriptase, RNaseH, andintegrase manufacture HIV deoxyribonucleic acid (“DNA”) out of thegenomic RNA. After the HIV DNA is manufactured within the cell, the HIVDNA enters the cell's nucleus and splices itself into one of that cell'schromosomes. At this point, the T4 cell is infected with the HIV virus.

Once the T4 cell is infected with the HIV virus, the T4 cell begins toreproduce copies, i.e., virions, of the HIV virus. One infected T4 cellcan produce approximately three hundred thousand to one million copiesof the HIV virus per infected T4 cell. Eventually, the infected T4 celllyses, which destroys the cell. The copies of the infecting HIV virusreleased from the destroyed T4 cell go on, however, to infect other T4cells. Since an infected T4 cell produces copies of the HIV virus fasterthan humans can produce T4 cells, eventually the immune system of theinfected person is overrun and is unable to fight off infection. This isbecause there are too few T4 cells left to create an immune response toinvading agents. It is these infections which eventually lead to thedeath of a patient from the HIV virus. Furthermore, copies of the HIVvirus are created faster than the antibody the body creates to fight it.Since the T4 cells are destroyed faster than they can be reproduced, thebody will never be able to create enough HIV antibody to fight thevirus.

The prior art teaches that infection by many viruses can be prevented byvaccination. Vaccination involves injecting an uninfected patient with aweakened or denatured virus. In response to the weakened or denaturedvirus, the body will create antibodies specific to that virus. Withrespect to the HIV virus, however, there is no known vaccine. Further,because the HIV virus mutates so rapidly, a vaccine may not be possible.The prior art does teach several drug therapies for a person infectedwith the HIV virus. Prior art drug therapies include Azidothymidine,known as AZT, Dideooxyinosine, known as ddI, and Zalcitabine, known asddc. Recently, a new class of drugs, for example Zidovudine, known asZDV, and Saquinavir, ddc known as Invirase™, have been used for treatingHIV infected patients. ZDV and Saquinavir are members of a class ofdrugs known as protease inhibitors. AZT tends to slow the HIV virus'reproduction cycle in humans. This lengthens the amount of time that ittakes for the HIV virus to completely destroy the immune system. ddI hasresults similar to AZT and tends to be used if AZT is too toxic for aparticular patient. ddc is generally used in combination with AZT totreat advanced HIV infection. AZT, ddI, and ddc are nucleotide analogueswhich make it difficult for the HIV virus to replicate by interferingwith the reverse transcriptase. ZDV and other protease inhibitors areanti-retroviral agents that interfere with the replication machinery ofHIV, resulting in non-infectious. Because the HIV virus mutates sorapidly, however, the virus within a patient eventually becomes immuneto protease inhibitors.

Further, prior art methods have developed whereby the patient takesseveral different medications at the same time. These drug combinationshave become known in the art as “cocktails.” Cocktails of these drugsare proving somewhat effective at delaying the destruction of the immunesystem by the HIV virus. However, the HIV virus eventually does overrunthe immune system in patients undergoing this therapy for the reasonsdiscussed above. Furthermore, such treatment is extremely disruptive tothe patient, as often the patient will be required to take thirty toforty pills at many different times during the day. The long-termresults of these three-drug combinations are not yet known. Furthermore,the cost of the three-drug combination is extremely high and istherefore beyond the reach of many infected individuals. Finally, thethree-drug treatments are not well tolerated by some patients.

Thus, there has been a long felt need for a treatment of subjectsinfected with blood-borne pathogens, such as the HIV virus, whichdestroys the pathogen.

SUMMARY OF THE INVENTION

Until the present invention, prior art treatments for subjects infectedwith viruses for which the body could not defeat with its own immunesystem only delayed death. For example, the prior art treatmentsdiscussed above for the HIV virus only lengthen the amount of time ittakes for the HIV virus to destroy the immune system, which leads todeath of the patient. The present invention provides a method andapparatus for destroying viruses such as the HIV virus, therebyeliminating the virus from the patient. The present invention utilizes alow intensity direct current to generate silver ions which destroy viralpathogens. The device operates in vivo via an exposed metal electrode inthe bloodstream. A first electrode is inserted into a patient's venoussystem. This first electrode comprises silver. In a preferredembodiment, the first electrode comprises an alloy of silver, copper andplatinum and traces of other metals. Then, a second electrode is placedon the patient's skin in the vicinity of the first electrode. Then, alow intensity direct current is applied to the first metal electrode.The low intensity direct current causes silver cations to be releasedfrom the electrode. The silver cations are attracted to the slight butdistinct negative polarities of blood borne viruses. The bonding of thesilver cation to the virus denatures the virus. The denatured virus isthen removed from the bloodstream by the patient's kidneys.

In another embodiment of the present invention, a first low intensitydirect current is applied to the first electrode for a first amount oftime. Then, a second low intensity direct current is applied to theelectrode for a second amount of time. The second amount of time is asignificantly longer period of time.

A preferred embodiment of the present invention comprises a catheterhaving a first lumen, a proximal end and a distal end. An electricalconductor extends through the first lumen. The electrical conductor isin electrical communication with the first electrode, which extends outof the distal end of the catheter. A power supply is in electricalcommunication with the electrode and supplies the low intensity directcurrent.

The above and other preferred features of the invention, includingvarious novel details of construction and combination of parts, will nowbe more particularly described with reference to the accompanyingdrawings and pointed out in the claims. It will be understood that theparticular devices embodying the invention are shown by way ofillustration only and not as limitations of the invention. As will beobvious to those skilled in the art, the principles and features of thisinvention may be employed in various and numerous embodiments withoutdeparting from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference is made to the accompanying drawings in which are shownillustrative embodiments of aspects of the invention, from which novelfeatures and advantages will be apparent

FIG. 1 is a perspective view of an embodiment of the present invention.

FIG. 2 is an expanded side view of an electrode for use in a preferredembodiment of the present invention.

FIG. 3 is a view in section of a dual lumen catheter of an embodiment ofthe present invention.

FIG. 4 is a view in section of a connection point of a wire and a leadcable of an embodiment of the present invention.

FIG. 5 is a perspective view of a main power cable for a preferredembodiment of the present invention.

FIG. 6 is a perspective view of a power supply for use with preferredembodiments of the present invention.

FIG. 7 is a view of an exit port for one lumen of a dual lumen catheterof an embodiment of the present invention.

FIG. 8 is a view in section of the distal end of a catheter of thepresent invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Ionic silver is useful in fighting bacterial infections and is widelyused as a bacteriostatic agent. For example, electrically generatedsilver ions are effective on infectious bacteria in deep puncture woundsand on broken bones that have become infected. There are someindications that silver ions generated in small quantities (i.e., lessthan twenty parts per billion) in the blood stream are effective indestroying bacterial pathogens but remain totally nontoxic to mammaliancells. Silver ions are also toxic to eukaryotic microorganisms in levelsas low as one to five parts per billion. The theories behind theeffectiveness of silver ions are as follows.

All biological life forms have a negative charge. This phenomena can bephotographed under certain conditions and is called an aura. Positiveelectrical energy is highly attracted to this negative polarization andis fatal to the life form when introduced directly, as in a human beingstanding near a tree in a lightening storm.

While this phenomena occurs in single cell and multi-cell animals, theindividual cells comprising the animal, while having slightly positiveor slightly negative polarities (it is these slightly positive andslightly negative polarities that allow magnetic resonance imagingsystems to function) have an electromagnetic field surrounding the cellthat is neutral. Therefore, because individual cells have polarity andare not polarized, positive cations are not attracted to individualcells.

As discussed, a virion is generally comprised of a core having nucleicacids and other protein-like substances and the virus' genomic RNA. Likethe nucleus of a eukaryotic cell, the viral core has a slight but adistinct positive polarity and a slight but a distinct negativepolarity. When the aggressive positive charges of the silver ions areplaced in the vicinity of a virus, it is believed that the silver ionsare attracted to the negative polarity of the core of the virus. Thisattraction leads to an ionic bond between the silver ion and thenegative polarity of the virus' core. This bond leads to an exchange ofa neutron between the silver ion and viral proteins. This leads toeither the denaturization of the viral proteins or the breaking of thebonds in the virus' DNA, thereby killing the virus. Once the virus iskilled, it is flushed from the blood by the patient's kidneys.

Silver salts such as silver chloride appear naturally in human bloodserum at concentrations of approximately thirty to eighty parts perbillion. Furthermore, silver is not reactive with body tissues. Thesecharacteristics, combined with the silver ion's efficacy in deactivatingviruses make it ideal for treating patients with blood borne viralinfections. However, one of ordinary skill in the art will recognizethat other ions from the class of heavy metals will work well using theconcepts of the present invention. An example of such heavy metalsincludes gold, zinc, copper, lead, and other metals capable ofelectrochemical reaction.

With reference to the drawings, presently preferred embodiments of thepresent invention will now be discussed. FIG. 1 shows a perspective viewof an embodiment 10 of the present invention. The embodiment 10 of FIG.1 comprises an elongated catheter 15. Catheter 15 is preferably made ofa biocompatible polymer material such as silicone rubber, polyurethane,or the like and depending upon where on the patient it will beinstalled, can be a peripherally inserted central catheter. While asingle lumen catheter is within the scope of the invention, a preferredembodiment of the present invention utilizes a dual lumen catheter 15comprising first lumen 20 and a second lumen 22, as shown in FIG. 3.First lumen 20 is preferably circular in shape so as to accommodate anelectrical conductor. Second lumen 22 preferably has a substantially “D”shape. Second lumen 22 is used to infuse medications or hydration fluidsinto the patient undergoing therapy while the embodiment 10 isinstalled. Second lumen 22 is particularly useful because patientsinfected with viruses are usually receiving many different medications,many of which could be dispensed through second lumen 22. Further,infected patients are often so dehydrated that their blood volume is toolow to allow the present invention to operate effectively. The “D” shapeof the second lumen 22, if used, maximizes the flow of fluids throughthis lumen 22.

Catheter 15 is fastened to bifurcation 25. Bifurcation 25 has a firstleg 27 and a second leg 29 and wings 30 having suturing holes 31. Firstlumen 20 branches into first leg 27 and second lumen 22 branches intosecond leg 29. Bifurcation 25 can be either integral with first andsecond legs 27, 29 or securely fastened to first and second legs 27, 29.Disposed in first lumen 20 and passing through first leg 25 is aconductive wire 32, which is best seen with reference to FIGS. 2 and 4.Wire 32 can be constructed of any electrical conductor, but ispreferably constructed of silver. In an alternative embodiment, catheter15 can have wire 32 extruded therethrough,

At the distal end of wire 32, anodal tip 35, i.e., an electrode, isinstalled thereon. Electrode 35 is fastened to wire 32 so that they areplaced in electrical communication with each other. Preferred fasteningtechniques include soldering, welding, or brazing. After installation ina patient, anodal tip 35 will reside exposed in the bloodstream of thepatient, as will be discussed below. At the proximal end of wire 32, alead cable 38 fastened thereto. Lead cable 38 is fastened to wire 32such that they are placed in electrical communication with each other.Preferred fastening techniques include soldering and welding. FIG. 4shows the connection point 42 of the wire 32 and the lead cable 38. Leadcable 38 is fastened to wire 32 within connector 41. A seal 43 is placedwithin connector 41 (see FIG. 4). Seal 41 seals the first leg 25 andfirst lumen 20 from reflux of blood or other body fluids. At theproximal end of lead cable 38 is electrical connector 39. In a preferredembodiment, electrical connector 39 is a female electrical connector.However, other electrical connectors can be utilized without strayingfrom the teachings of the present invention.

As discussed, second lumen 22 branches into second leg 29 at bifurcation25 such that second leg 29 remains in fluid communication with lumen 22.Disposed on the side of catheter 15 is an exit port 45 (see FIG. 7).Exit port 45 is preferably one to two inches from the distal tip ofcatheter 15 so that any effluents released therefrom are not prematurelymixed into the ion field created by electrode 35. Lumen 22 initially mayhave a guidewire or stylet 48 slidably pre-inserted. Pre-inserted stylet48 extends from lumen 22, through bifurcation 25 and leg 29. At the endof leg 29 is preassembled hub 51 which preferably has a Luer fitting 53integral thereto. Stylet 48 extends out of leg 29 and passes throughflushing assembly 55. Flushing assembly 55 comprises a three-wayconnector 56 having an inlet port 58, an outlet port 60, and a flushingport 62. Flushing assembly 55 has a Luer fitting 65 at the outlet port60 which mates with the Luer fitting 53 on leg 29. A reclosable septum67 is affixed at the inlet port 58. Septum 67 is preferably constructedof a resilient rubber material. The resilient nature of the rubberreclosable septum 67 is such that it makes a water tight seal around thestylet 48. The reclosable septum 67 provides a slight resistance tomovement of the stylet 48. This resistance prevents the stylet 48 frombeing moved too quickly through the flushing assembly 55, leg 29 andcatheter 15. This is advantageous since moving too quickly can causepatient discomfort and may result in puncturing the catheter 15 by thestylet 48. Puncturing the catheter 15 in an infected patient can be aserious problem since the user's ability to repair the damaged vein maybe compromised by wire 32. Further, once stylet 48 is removed, thereclosable septum 67 forms a watertight barrier, which prevents thereflux of blood. The stylet 48 passes through lumen 22, leg 29, outletport 60 inlet port 58 and reclosable septum 67. A stylet handle 69 maybe placed at the end of the stylet 48 which emerges from the flushingassembly 55. Stylet handle 69 allows the installer to manipulate thestylet 48 during insertion so that the catheter can be maneuvered aroundobstructions in the patient's venous system.

The flushing port 62 of the flushing assembly 55 is used to add fluidssuch as flushing solutions to lumen 22 to aid in the installation of thecatheter 15 into a patient. Flushing solutions also make removal of thestylet 48 after installation easier, as the fluids can lubricate thestylet 48. Flushing solutions are added to flushing assembly 55 byaffixing a syringe (not shown) to flushing port 62. When a syringe isnot affixed to flushing port 62, a cap 72 may be placed over theflushing port 62. A preferred flushing apparatus and method aredisclosed in U.S. Pat. No. 5,357,961. U.S. Pat. No. 5,357,961 isassigned to the assignee of the present invention, and is incorporatedherein by reference in its entirety.

FIG. 2 shows a detailed view of an embodiment of the electrode 35 usedin the present invention. The electrode 35 is frictionally attached tothe catheter 15 at the catheter's distal end 75 and preferably isone-half inch long and 0.03 inches in diameter. The security of the fitbetween the distal end 75 of catheter 15 and the electrode 35 isimportant as it is highly desirable to prevent fluids such as blood orother fluids from leaking around the electrode 35 and into lumen 20.Catheter 15 preferably tapers at its distal end 75 to allow for a smoothtransition into electrode 35 (see also FIGS. 7 and 8). Approximatelyeighty percent of the electrode 35 is uninsulated and therefore exposed.That portion of the electrode 35 that resides within lumen 20 ofcatheter 15, along with wire 32, is preferably covered by insulation 77.Insulation 77 is preferably a biocompatible insulation material such asparylene. Other polymers like parylene can be used as an acceptableinsulation material. In a preferred embodiment, the electrode 35 is analloy comprised of 97.8 percent silver, 0.2 percent copper, and 2.0percent platinum. While the silver component produces the ions mostreactive with viruses, the copper and platinum of electrode 35 providevery important features. The platinum acts as a catalyst and aids in therelease of the silver ions from the electrode 35. The platinum alsohelps to prevent oxides from building up on the electrode 35. The copperacts to control the release of silver ions from the electrodes. Inparticular, the copper causes the silver ions to be released in shortbursts.

FIG. 3 shows a cross-sectional view of a dual lumen catheter 15. Asdiscussed, the present invention contemplates the use of a single lumencatheter as well as the dual lumen catheter shown in FIG. 3. If a singlelumen catheter is used, only lumen 20, which contains wire 32, will bepresent. If fluids or medications are infused into the patient'sbloodstream, other means will be required. In addition, the presentinvention contemplates the use of catheters having more than two lumens,such as a triple lumen catheter.

FIG. 4 shows a cross sectional view of the electrical connection of wire32 to lead cable 38 inside connector 41. Connector 41 fits snugly withinfirst leg 27, as shown in FIG. 4. A Luer fitted cap 44 fits overconnector 41.

FIG. 5 shows a main power cable 85 of an embodiment of the presentinvention. Power cable 85 is comprised of a main cable 88 and twoseparate branches 90 and 92. First branch 90 terminates at an electricalconnector 95. Electrical connector 95 can be securely connected toelectrical connector 39. In a preferred embodiment, electrical connector95 is a male connector. Second branch 92 terminates an electrode pad 98.Electrode pad 98 can be an EKG pad. Main cable 88 terminates at anotherelectrical connector 100. In a preferred embodiment, electricalconnector 100 is a male electrical connector.

FIG. 6 shows a power supply 110 which is used to apply power to theelectrode 35. Electrical connector 100 of power cable 85 fits securelywithin a jack 112 on power supply 110. In a preferred embodiment, jack112 is a female electrical socket which can receive connector 100 frompower cable 85. Also on power supply 110 is a display 115 which, whenilluminated, indicates that the power supply 110 is supplying current tothe electrode 35. A switch 118 is provided which allows the amount ofcurrent to be varied. In a preferred embodiment, switch 118 has twopositions which provide two different levels of current to electrode 35.The amount of current supplied at the two different positions will bediscussed below. Using the teachings of the present invention, however,it is possible that different types of switches may be provided so thatmore than two levels of current can be supplied to the patient. Further,in another preferred embodiment, the power supply 110 is able toautomatically switch between the different levels of current that mustbe supplied to treat the virus which the patient is infected with. Powersupply 110 is preferably housed in a sealed case 120 constructed of amaterial that can be sterilized with ethyleneoxide. Power supply 1 10should be powered by a self-contained power source such as a batterywhich is capable of providing the power necessary for a substantiallength of time, e.g., six-to-eight weeks. In a preferred embodiment, thepower supply 110 is powered by a nine volt alkaline battery which issealed within case 120. Preferably, provisions are made to allow thereplacement of the battery should the need arise. In another embodiment,the power supply can be powered by a 1.5 volt alkaline battery.

FIGS. 7 and 8 show the distal end of catheter 15. FIG. 7 shows apreferred embodiment of exit port 45. Presently preferred exit port 45comprises an axially oriented, oval-shaped opening 123 and an axiallyoriented slit 121 extending from an end of opening 123 towardbifurcation 25. Slit 121 is expandable from a closed position to an openposition. Slit 121 opens by separating the top and bottom portionsbeginning at the opening 121. An embodiment of such a side port is foundU.S. patent application Ser. No. 08/660,020, filed on Jun. 6, 1996, nowU.S. Pat. No. 5,776,096. This application is incorporated herein byreference.

As will be discussed below, the power supply 110 supplies a lowintensity direct current to the electrode 35. Because the electrode 35releases silver cations, there is a chemical reaction that occurs on thesurface of the electrode involving silver and oxygen that results in anonconductive oxide on its surface. Over the treatment period, thisoxide increases the surface resistance on the electrode 35. Thisincreased resistance requires that the power supply 110 increase thevoltage applied to the electrode 35 to produce the same number of silverions throughout the treatment period. Thus, in a preferred embodiment,the power supply 110 adjusts its voltage to maintain the proper currentlevel and hence voltage level. However, at 0.88 volts and higher, theoxide can be forced off of the electrode, which could cause blood clots,stroke and the like. Therefore, a preferred embodiment of the presentinvention has a voltage limit of 0.86 volts. If the power supply 110 isrequired to supply more than 0.86 volts, it will shut down. In apreferred embodiment, the power supply 110 has a display (not shown)which would inform the clinician or the patient that the power supply110 has shut down. The display could also provide other pertinentinformation such as the level of current and voltage being supplied andthe elapsed time of treatment. An audible warning can also be providedthat is indicative of a possible malfunction. In the case where thepower supply 110 shuts down because it exceeded 0.86 volts, theapparatus 10 can be removed and a new one can be installed in the mannerdescribed herein. The current supply capability of the electronics ofpower supply 110 will be discussed below.

In another preferred embodiment of the present invention, the powersupply 110, cable 85 and apparatus are integral with each other.

The method of installation of the apparatus 10 of the present inventionwill now be discussed. One of ordinary skill in the art will recognizethat many other installation procedures may be appropriate dependingupon the patient and the preferences of the installer. Prior toinstallation, a proper location must be found on the patient forinsertion of the catheter. Generally, a location on one of the arms ofthe patient is selected where venous introduction will be possible.Because patients infected by such blood borne viruses as HIV virus mayhave experienced severe weight loss, disease and other problems, thepresent invention can be installed through the veins or arteries inareas of the body other than the arm. For example, the apparatus 10 canbe installed in the jugular vein of a patient.

As discussed, a stylet 48 is runs the length of lumen 22 of catheter 15.Stylet 48 makes installation of the apparatus 10 easier because itstiffens catheter 15, which makes pushing it through a patient's venoussystem easier. This is especially important in patients severelyaffected by viruses because they are often dehydrated. Dehydration makespassing catheters through the venous system difficult, as there is lessblood volume. Stylet 48 preferably comprises a hydrophilically coated,twist-braided stylet. As discussed, handle 69 provides a larger surfacewhich makes manipulating the stylet 48 easier. This can reduce theamount of time it takes to install the catheter. Shortened installationtimes are especially important with infected patients because duringinstallation, blood can reflux from the patient, which can place theinstaller in danger of infection.

After the installation site is selected, it is prepared for apparatus 10insertion. If desired, a small amount of flushing solution can beflushed through flushing port 62 and into leg 29 and lumen 22. Flushingprior to installation allows the user to check for patency. The userwill know that the catheter 15 has been successfully flushed when dropsof flushing solution begin to emerge from the exit port 45 of secondlumen 22. After ensuring patency, the vein is punctured through the skinusing a catheter introducer (not shown). Suitable introducers includethe SAFE-T-PEEL® brand break-away introducer from HDC Corporation andany other over the needle type peel away introducer. After theintroducer provides access to the patient's vein, the catheter 15 isthreaded through the patient's venous system until the electrode 35reaches his or her superior vena cava. As will be discussed below, thesuperior vena cava is the preferred location for the electrode 35.

While threading the catheter 15 through the patient, it may be necessaryto flush the second lumen 22 of catheter 15 to aid in installation. Whenthe second lumen is flushed during installation, the flushing solutionwill act to slightly move the tip of catheter 15, thereby allowing it tomove past any venous obstruction. Flushing during installation can alsoremove any blood that may accumulate inside the second lumen 22. Afterthe apparatus 10 is installed in the patient and the electrode 35 isplaced within the superior vena cava, the stylet 48 should be removedfrom the second lumen 22. To remove the stylet 48, the stylet's 35handle 69 is pulled. If any resistance is felt, the second lumen 22 canbe flushed. As discussed above, the flushing solution lubricates thestylet 48, thereby making removal much easier. Once the electrode 35 isproperly placed, apparatus 10 can be affixed to the patient via suturingholes 31.

Once the apparatus 10 is installed in the patient, the main cable 85 isinstalled. The electrode pad 98 is affixed to the exterior skin of thepatient such that it is in close proximity to the electrode 35 installedwithin the patient. Then, connector 95 at the end of branch 90 of cable85 in is connected to connector 39 on lead cable 38. Then, connector 100on main cable 88 is connected to jack 112 on power supply 110. Asdiscussed above, in another preferred embodiment, the power supply 110,cable 85 and apparatus 10 are integral with each other. Such anarrangement eliminates the need for the installer to make theseconnections. As it will be necessary for an apparatus of the presentinvention to remain installed in the patient for a long period of time,the apparatus 10, cable 85 and power supply 110 should be arranged onthe patient so that the patient can remain comfortable and have theability to move about.

The present invention operates by providing a low intensity directcurrent to electrode 35. By placing the electrode pad 98 on the surfaceof the patient in the vicinity of electrode 35, the low intensity directcurrent will cause the electrode 35 to act as an anode, therebyreleasing metal ions into the bloodstream of the patient. Thesepositively charged metal ions are attracted to the negative polarity ofthe virus, thereby destabilizing it, as discussed above. The superiorvena cava of the patient is the preferred location for installation ofelectrode 35 because it is the largest blood vessel in the body. The useof such a large blood vessel is preferred because metal ions such as thepreferred silver ion have a half life of approximately seven seconds.The device as will be seen below, creates an average output offour-hundred billion silver cations per second. With an average bloodvolume of four liters passing by the electrode 35 approximately twiceper minute, the probability of a virus passing by the electrode 35 andbeing bonded to a metal ion increases when the volume of blood availableto carry the virus is higher. Thus, placing the electrode 35 in thesuperior vena cava will increase the probability that metal ionsgenerated by the apparatus 10 will bond to a virus in the bloodstream.

It is very important that the amount of metal ions entering thebloodstream from the apparatus 10 be controlled so that while largenumbers of virus are killed, the patient is not harmed. The human bodyhas naturally occurring silver ions as components of stable saltspresent in the bloodstream. These particular silver ions are present inhuman blood serum in concentrations of approximately thirty to eightyparts per billion as previous experiments have shown. However, thesenaturally occurring ions are associated with other negatively chargedions. Because of this, they are not attracted to the viruses present inthe bloodstream and therefore cannot kill any viruses.

In the presently preferred method of administering metal ions to aninfected patient, the patient is initially flooded with large amounts ofmetal ions for a relatively short period of time. The reason for this isthat a patient infected with a pathogen such as the HIV virus may havetwo million or more copies of the virus per milliliter of blood. Withthe average human having approximately four-thousand milliliters ofblood, an infected individual may have approximately eight billioncopies of the virus that must be bonded to a silver ion. Since silverions have a relatively short half-life (approximately seven seconds), asignificantly larger number of silver ions must be produced than thereare viruses because the probability of a silver ion bonding to virus ismuch lower than one-hundred percent However, the need for large numbersof silver ions must be balanced with the need to keep the silver contentwithin levels safe for humans. Since humans can withstand onlyapproximately thirty to eighty parts per billion of silver in the bloodserum without resulting in a toxic reaction, it is important that thepresent invention not introduce more than this safe amount into thebloodstream.

To balance the need for large numbers of silver ions with the need tokeep the amount of silver within safer ranges for humans, the powersupply 110 supplies two and one-half microamps of current for twelveminutes at the beginning of treatment. This produces 1.56×10(13) ions ofsilver per second. During the twelve minutes (i.e., seven-hundred twentyseconds) that the power supply 110 supplies two and one-half microampsof current, 0.0018 Coulombs enters the bloodstream (i.e., seven-hundredand twenty seconds multiplied by two and one-half microamps). UnderFaraday's law, one mole of silver ions equals 96485 Coulombs. Further,one mole of silver ions weighs 107.87 grams. Thus, in the initial twelveminute operating period, nearly two micrograms (1.94 micrograms) ofsilver ions are introduced into the bloodstream. This is less than fiveparts per billion silver content in the blood serum, which issignificantly below the level of harmful silver content within a human.Thus, during the initial twelve minute treatment using the concepts ofthe present invention, the silver content does not exceed toxic levels.

After the initial twelve minute operating period, the low intensitydirect current provided by power supply 110 is reduced to one-hundredtwenty five nanoamps. This causes the production of silver ions to beproduced at a rate of seven-hundred seventy-four billion ions persecond. Under a preferred embodiment of the present invention, thislevel of electric current is maintained for a period of seventy-onehours and forty-eight minutes. During this time (i.e., 258,480 seconds)that the power supply 110 supplies one-hundred twenty-five nanoamps ofcurrent, 3.2×10(−4) Coulombs enters the bloodstream (i.e., 258,480seconds multiplied by one-hundred twenty-five nanoamps). Under Faraday'slaw, one mole of silver ions equals 96485 Coulombs. Further, one mole ofsilver ions weighs 107.87 grams. Thus, during this entire period, onlyapproximately 36.1 micrograms of silver ions are introduced into thebloodstream. Thus, in the entire seventy-two hour treatment, only 38.1micrograms of silver have been introduced into the patient'sbloodstream. This is less than nine parts per billion silver content inthe blood serum for a seventy-two hour period, which is significantlybelow the range for harmful silver content within a human.

The present invention, in addition to providing a non-toxic level ofsilver ions into the bloodstream, does not exceed unsafe levels ofcurrent. Low intensity direct currents of two and one-half microamps andone-hundred twenty five nanoamps is far lower than the current levelsprovided by, for example cardiopacing devices. Thus, the small amountsof silver ions introduced into the patient's bloodstream coupled withthe extremely low currents result in a treatment that, in addition tobeing highly effective, is also physiologically safe.

The concepts of the present invention have been tested on subjects andresulted in highly positive results. In a first example, the humanpatient had 2,165,823 copies of the HIV virus per milliliter of blood bythe RNA PCR quantification test method. In addition, this patient's T4cell (Helper) count was at 18. This particular subject was experiencingserious kidney malfunction prior to treatment. Twenty-four hours aftertreatment, this patient's viral load was reduced to 1,336,817 copies ofthe HIV virus per milliliter of blood while the T4 cell count was 11.Because of this patient's kidney malfunction, it was suspected that mostof the viral copies detected during the RNA PCR quantization test hadbeen denatured but had not yet been removed from the patient by thekidneys. Thus, one month after treatment, the viral load was measuredagain and found to be reduced to 621,215 copies of the HIV virus permilliliter of blood. After treatment, the patient immediately feltimproved health, was able to eat solid food, and experienced a dramaticincrease in quality of life.

A second human subject had a viral load of 1,814,466 copies of the HIVvirus per milliliter of blood (RNA PCR quantification method) and a T4cell count of 17. This patient was too dehydrated to place the electrode35 into the superior vena cava. Thus, the electrode 35 was placed in thesubclavian vein. This patient was subjected to twelve minutes oftreatment at 2.5 microamps and then only forty-seven hours andforty-eight minutes of treatment at one-hundred twenty-five nanoamps.Forty-eight hours after treatment, the patient's viral load and T4 cellcount were measured to be 394,972 copies of the HIV virus per milliliterof blood (RNA PCR quantization method) and 18, respectively. Once again,this patient immediately felt improved health and was able to eat solidfood.

A third human subject had a viral load of 693,832 copies of the HIVvirus per milliliter of blood (RNA PCR quantification method) and a T4cell count of 5. This patient was also undergoing treatment with AZT.For this patient's treatment, the initial twelve minutes of treatment at2.5 microamps was followed by seventy hours and eighteen minutes oftreatment at one-hundred twenty-five nanoamps. Twenty-four hours aftertreatment, the patient's viral load and T4 cell count were measured tobe 634 copies of the HIV virus per milliliter of blood (RNA PCRquantization method) and 6, respectively. Once again, this patientimmediately felt improved health, was able to eat solid food, andexperienced a dramatic increase in quality of life.

In a presently preferred method for practicing the invention, the lowintensity direct current is maintained for a longer period of time thanthe seventy-two hour period discussed above. The reason for this is thatit is currently believed that it takes approximately six weeks for anHIV virus that infects a cell to cause that cell to lyse (i.e., burst).Any viruses that infected a cell immediately prior to treatment with themethods of the present invention could avoid being denatured by a metalion while reproducing in a T4 cell. Thus, for a six week periodfollowing treatment, T4 cells will lyse, causing new HIV virions toenter the bloodstream. These new HIV virions can eventually infect newcells. Because of this, while the patient's health may be improved inthe short term, the HIV virus will once again work to destroy the immunesystem in the fashion discussed above. Thus, in a presently preferredembodiment, the patient receives an initial treatment of 2.5 microampsfor twelve minutes. Then, the low intensity direct current is lowered toone-hundred twenty-five nanoamps for a period of six weeks by doingthis, the invention can denature the HIV virions produced by lysingcells after treatment begins. By doing so, virtually all of the HIVvirions can be denatured, thereby resulting in a potential cure.

The methods of this invention have also been successfully tested on adifferent virus and a different host: namely, a cat infected with felineimmunodeficiency virus (“FIV”). A seven year old male house cat weighingten pounds and ten and three-quarter ounces had “heavy third eyelid”,some hair loss, eleven bite marks along his back and rump, and a woundto the top of the ear, all indicative of acute disease. The cat wasanesthetized with ketamine, a catheter was placed in the neck, and thenegative electrode was placed on the underchest. Approximately fourmicrograms of silver was delivered in twenty-four minutes, followed byone-half a microgram of silver per hour for ninety minutes. The nextmorning the subject cat had returned to normal activity and appetite.

Thus, method and apparatus for the treatment of blood borne viralinfections such as human immunodeficiency virus and felineimmunodeficiency virus is disclosed. While embodiments and applicationsof this invention have been shown and described, it would be apparent tothose skilled in the art that many more modifications are possiblewithout departing from the inventive concepts herein. The invention,therefore is not to be restricted except in accordance with the scope ofthe appended claims. Furthermore, one skilled in the art will recognizethat the present invention is useful for treating infections other thanthe HIV virus. For example, the teachings of the present invention wouldbe effective at treating patients infected with such blood-bornepathogens as bacteria, fungi, Rickettsia, etcetera.

We claim:
 1. An apparatus comprising: a catheter having a first lumenand a second lumen, a proximal end and a distal end; a bifurcationfitted at said proximal end of said catheter, said bifurcation having afirst leg and a second leg, said first leg having a first connectorattached thereto, said second leg having a second connector attachedthereto; an electrode extending out of said distal end of said catheterfor the in situ creation and release of cations from the electrodedirectly into the blood of a venous system of a patient, an electricalconductor extending through said first lumen and said first leg of saidbifurcation, said electrical conductor being in electrical communicationwith said electrode; a lead cable electrically connected to saidelectrical conductor at said first connector; a main cable, said maincable comprising a first branch and a second branch, said first branchelectrically connected to said lead cable, said second branchelectrically connected to an electrode pad; an electrode pad disposed onthe patient; a power supply, said power supply in electricalcommunication with said first branch of said main cable and saidelectrode pad, said power supply adapted to supply direct current tosaid electrode; and a catheter flushing apparatus connected to saidsecond connector, said catheter flushing apparatus having a styletextending from said catheter flushing apparatus, said second leg of saidbifurcation and said second lumen of said catheter.
 2. The apparatus ofclaim 1 wherein said electrode is comprised of silver.
 3. The apparatusof claim 1 wherein said electrode is comprised of silver, platinum andcopper.
 4. The apparatus of claim 3 wherein said electrode is comprisedof approximately 97.8 percent silver, 0.2 percent-copper, and 2.0percent platinum.
 5. The apparatus of claim 1 wherein said catheterfurther comprises an side portal which allows fluids to exit said secondlumen.
 6. The apparatus of claim 1 wherein said second lumen has a Dshape.
 7. An apparatus comprising: (A) a catheter having a first lumenand a second lumen, a proximal end and a distal end; (B) a bifurcationfitted at said proximal end of said catheter, said bifurcation having afirst leg and a second leg, said first leg having a first connectorattached thereto, said second leg having a second connector attachedthereto; (C) a first electrode extending out of said distal end of saidcatheter for the in situ creation and release of cations from theelectrode directly into the blood from the circulatory system of apatient; (D) an electrical conductor extending through said first lumenand said first leg of said bifurcation, said electrical conductor beingin electrical communication with said first electrode; (E) a lead cableelectrically connected to said electrical conductor at said firstconnector; (F) a main cable, said main cable comprising a first branchand a second branch, said first branch electrically connected to saidlead cable, said second branch electrically connected to a secondelectrode; (G) a second electrode; (H) a power supply, said power supplyin electrical communication with said first branch of said main cableand said second electrode, said power supply adapted to supply directcurrent to said first electrode; and (I) a catheter flushing apparatusconnected to said second connector, said catheter flushing apparatushaving a stylet extending from said catheter flushing assemblyapparatus, said second leg of said bifurcation and said second lumen ofsaid catheter.
 8. The apparatus of claim 7 wherein said first electrodeis comprised of silver.
 9. The apparatus of claim 7 wherein said firstelectrode is comprised of silver, platinum and copper.
 10. The apparatusof claim 9 wherein said first electrode is comprised of approximately97.8% silver, 0.2% copper, and 2.0% platinum.
 11. The apparatus of claim7 wherein said catheter further comprises a side portal which allowsfluids to exit said second lumen.
 12. The apparatus of claim 7 whereinsaid second lumen has a D shape.
 13. An apparatus comprising: a catheterhaving a first lumen, a proximal end and a distal end; an electricalconductor extending through said first lumen; an electrode extending outof said distal end of said catheter for the in situ creation and releaseof cations from the electrode directly into the blood of a venous systemof a patient, said electrode being solid and in electrical communicationwith said electrical conductor, said electrode defining a distal endconfigured and dimensioned for passage through the patient's skin andinto the blood of the patient's venous system; said electrode iscomprised of approximately 97.8 percent silver, 0.2 percent copper, and2.0 percent platinum; and a power supply, said power supply inelectrical communication with said electrode and with an electrode padon the patient.
 14. An apparatus comprising: a catheter having aproximal end and a distal end; an electrical conductor extending throughsaid catheter; an electrode extending out of said distal end of saidcatheter for the in situ creation and release of cations from theelectrode directly into the blood of a venous system of a patient, saidelectrode defining a distal end configured and dimensioned for passagethrough the patient's skin and into the blood of the patient's venoussystem, said electrode being in electrical communication with saidelectrical conductor; said electrode is comprised of approximately 97.8percent silver, 0.2 percent copper, and 2.0 percent platinum; and apower supply, said power supply in electrical communication with saidelectrode and with an electrode pad on the patient.
 15. An apparatuscomprising: (A) an electrically insulative member having a first lumen,a proximal end and a distal end; (B) an electrical conductor extendingthrough said first lumen; (C) a first electrode extending out of saiddistal end for the in situ creation and release of cations from the saidfirst electrode directly into the blood from the circulatory system of apatient, said first electrode defining a distal end configured anddimensioned for passage through the patient's skin and into the blood ofthe patient's venous system, said first electrode being solid and inelectrical communication with said electrical conductor; said firstelectrode is comprised of approximately 97.8 percent silver, 0.2 percentcopper, and 2.0 percent platinum; and (D) a power supply, said powersupply in electrical communication with said first electrode and with asecond electrode, said second electrode being in electricalcommunication with said first electrode via the patient's blood.
 16. Anapparatus comprising: (A) a catheter having a proximal end and a distalend; (B) an electrical conductor extending through said catheter; (C) afirst electrode extending out of said distal end of said catheter forthe in situ creation and release of cations from the electrode directlyinto the blood from the circulatory system of a patient, said firstelectrode defining a distal end configured and dimensioned for passagethrough the patient's skin and into the blood of the patient's venoussystem, said first electrode being in electrical communication with saidelectrical conductor; said first electrode is comprised of approximately97.8 percent silver, 0.2 percent copper, 2.0 percent platinum; and (D) apower supply, said power supply in electrical communication with saidfirst electrode and with a second electrode, said second electrode beingin electrical communication with said first electrode via the patient'sblood.
 17. A method for the destruction of blood borne pathogenscomprising: (A) inserting a first metal electrode into a patient'sblood, said the first metal electrode comprising silver; (B) placing asecond electrode in electrical communication with the first metalelectrode via the patient's blood; (C) applying a first low intensitydirect current to the first metal electrode for a first period of time;said first low intensity direct current is approximately two andone-half microamps; and (D) applying a second low intensity directcurrent to the first metal electrode for a second period of time; saidsecond low intensity direct current is approximately one hundred andtwenty-five nanoamps.
 18. The method of claim 17 wherein said firstperiod of time is approximately twelve minutes and said second period oftime is approximately seventy-one hours and forty-eight minutes.
 19. Themethod of claim 17 wherein said first period of time is approximatelytwelve minutes and said second period of time is approximately sixweeks.
 20. Apparatus for the destruction of a blood borne viral pathogencomprising: (A) a first electrode for the in situ creation and releaseof cations from the electrode directly into the blood of a patient'svenous system, the first electrode being at least partially disposed ina catheter lumen and having an exposed portion extending out of thedistal end of the catheter lumen and a non-exposed portion disposedwithin the catheter lumen; (B) a second electrode for placement on apatient's skin; (C) conductive means for electrically connecting thefirst and second electrodes to power supply means; and (D) power supplymeans for applying low-intensity direct current to the first electrodein a pattern sufficient to destroy the blood borne viral pathogenthrough the release of pathogen-binding cations from the first electrodeinto the blood of the venous system of the patient.
 21. The apparatus ofclaim 20 wherein the first electrode includes an electrical conductorportion disposed within the catheter lumen and an electrode portionextending out of the distal end of the catheter lumen for the in situcreation and release of cations directly from the electrode directlyinto the blood of the venous system of a patient, the electrode portionbeing in electrical communication with the electrical conductor portionand releasing pathogen-binding silver cations.
 22. Apparatus for thedestruction of a blood borne viral pathogen comprising: (A) a firstelectrode for the in situ creation and release of cations from theelectrode directly into the blood from a patient's venous system, saidfirst electrode being at least partially disposed in a catheter lumenand having an exposed portion extending out of the distal end of thecatheter lumen and a non-exposed portion disposed within the catheterlumen; (B) a second electrode, said second electrode being in electricalcommunication with said first electrode via the patient's blood; (C)conductive means for electrically connecting said first and secondelectrodes to power supply means; and (D) power supply means forapplying low-intensity direct current to said first electrode in apattern sufficient to destroy the blood borne viral pathogen through therelease of pathogen-binding cations from said first electrode into theblood from the circulatory system of the patient.
 23. The apparatus ofclaim 22 wherein said first electrode includes an electrical conductorportion disposed within the catheter lumen and an electrode portionextending out of the distal end of the catheter lumen for the in situcreation and release of cations from the electrode directly into theblood from the circulatory system of a patient, said electrode portionbeing in electrical communication with said electrical conductor portionand releasing pathogen-binding silver cations.